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Portsmouth ethicist advises government on clinical trials

Ethicist Dr Simon Kolstoe CREDIT: Stefan & Sara Venter –

University of Portsmouth ethics expert Dr Simon Kolstoe has helped inform a new government report, out today, examining whether failing to publish data from clinical trials presents a risk to human health.

The House of Commons Science and Technology Committee has expressed concern that nearly half of clinical trials fail to publish their results, and today it is calling for increased transparency.

The committee’s report was compiled following extensive expert evidence, including from Dr Kolstoe.

The Health Research Authority (HRA) has been responsible for ‘promoting research transparency’ since 2014, but the committee concluded that not enough had been done to improve reporting rates.

The committee wants the HRA to produce a strategy for fixing this problem and believes its performance should be measured against progress. Witnesses pointed to explicit examples of ‘publication bias’ leading to wasted public expenditure in the UK and even patient deaths in other countries.

The committee had heard evidence that the HRA could use automated tools to search databases to confirm if a trial had published results in an academic journal. Dr Kolstoe argued that doing so would “solve less than half of the problem”, since “determining whether results have been posted does not address whether they appropriately represent the study that was actually conducted”.

He told the committee that while it could be “relatively cheap and easy” to audit non-publication, in order to address “outcome reporting bias” a manual comparison would need to be made of the final study reports against the original proposal.

Dr Kolstoe has previously conducted such an audit for the Hampshire A Research Ethics Committee to demonstrate that it was possible, and he argued that those with access to REC records were “in a particularly powerful position to detect publication and reporting bias in contrast to similar attempts conducted by research funders or systematic review organisations who do not have immediate access to such a wide range of otherwise confidential protocols”.

The examples included the government’s decision to stockpile millions of pounds’ worth of Tamiflu in response to the H1N1 ‘Swine Flu’ epidemic in 2009, when the committee heard from Dr Kolstoe that the government was “relying on a marketing spiel claiming successful trials of this drug rather than being able to consider the actual evidence of the drug efficacy for themselves”.

And despite “over 500 individually named academic journals” having formally endorsed the CONSORT guidelines for trial reporting, mis-reporting remains an issue. A study of the work of Hampshire A Research Ethics Committee by Dr Kolstoe found that 57 per cent of publications associated with trials approved by the committee showed “inconsistencies with the outcomes originally declared in the ethics application”.

Norman Lamb, MP and chair of the committee, said: “An astounding amount of information from clinical trials is going unreported. The Health Research Authority must act now to ensure current regulations are enforced and impose tough sanctions on those who seem to think it is acceptable to disregard valuable research, threaten research integrity and, in some cases, endanger human life.

“Many of these trials are funded with public money and the tax payer has a right to expect those who benefit from public funding to follow the rules and publish in full.

“It is particularly disappointing that trusted bodies such as Public Health England and a range of NHS Foundation Trusts are failing to report results from clinical trials. Public trust in medicine could easily be eroded by these failings from such important parts of the health system.

“People take part in these trials in good faith, hoping to help inform doctors and decision makers on vital issues affecting many of us every day. Their efforts are betrayed if the results are not made available at the end.

“The Health Research Authority must be provided with all of the necessary funding it needs to produce an official list of which trials have reported results and which ones haven’t. We would urge the Health Research Authority to prioritise this issue and are disappointed with progress in tackling the issue over the past four years.”

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